Centralization and Oncologic Outcomes in Ovarian Cancer
NCT ID: NCT07075939
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2025-06-27
2030-06-30
Brief Summary
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The study aims to evaluate the impact of surgical centralization and treatment strategies adopted during the COVID-19 pandemic on oncologic outcomes in patients diagnosed with the epithelial ovarian cancer (EOC) from 2018 to 2023.
The retrospective component includes patients treated between 2018 and 2023, while the prospective component consists of clinical follow-up of those patients over the next five years.
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Detailed Description
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Shortly thereafter, the onset of the COVID-19 pandemic led to a severe reduction in healthcare resources, including surgical capacity, ICU beds, and staff availability. This situation resulted in a higher proportion of patients being referred for neoadjuvant chemotherapy, with surgery performed mainly in selected patients with better performance status and higher chances of complete resection. During this period, an increase in centralized treatments, multidisciplinary evaluations, BRCA testing, and use of interval debulking surgery (IDS) was observed.
This observational, retrospective study is designed to evaluate whether centralization and pandemic-related treatment modifications influenced oncological outcomes. The primary objective is to compare progression-free survival (PFS) and overall survival (OS) among patients treated during three different timeframes: pre-centralization/pre-pandemic (2018-2019), peak pandemic phase (2020-2021), and pandemic control phase (2022-2023). Secondary objectives include describing treatment strategies after initial diagnosis (type of surgery, chemotherapy, maintenance therapies), tumor characteristics (histology, BRCA/HRD status), recurrence patterns (site, symptoms, treatment), and the proportion of patients receiving secondary surgery, radiotherapy, Bevacizumab, and/or PARP inhibitors. No experimental interventions are included, and all patients received treatment according to routine clinical practice.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Pre-pandemic cohort (Group A)
Patients with epithelial ovarian cancer treated between January 2018 and December 2019, before the implementation of centralization policies and before the onset of the COVID-19 pandemic. Standard care was provided based on local resources and clinical practice guidelines at the time.
No Intervention: Observational Cohort
Observational data collection only
Pandemic peak cohort(Group B)
Patients treated between January 2020 and December 2021, during the most critical phase of the COVID-19 pandemic. Centralization of care and multidisciplinary decision-making were consistently applied.Treatment decisions were influenced by reduced hospital resources, increased use of neoadjuvant chemotherapy, and enhanced centralization of surgical procedures.
No Intervention: Observational Cohort
Observational data collection only
Post-peak pandemic cohort(Group C)
Patients treated between January 2022 and December 2023, during the phase of pandemic control. Centralization of care and multidisciplinary decision-making were consistently applied. This group reflects the new post-pandemic organizational standards.
No Intervention: Observational Cohort
Observational data collection only
Interventions
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No Intervention: Observational Cohort
Observational data collection only
Eligibility Criteria
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Inclusion Criteria
* Histological and/or cytological diagnosis of epithelial ovarian cancer
* Patients evaluated by the Multidisciplinary Tumor Board (MTB) of the AUSL-IRCCS of Reggio Emilia
* Patients treated between January 1, 2018, and December 31, 2023
* Availability of clinical records and outcome data
* Signed informed consent where possible, in accordance with GDPR and Italian regulations
Exclusion Criteria
* Incomplete or missing data for key clinical indicators
* Patients unable to provide informed consent and for whom recontact is not possible
* Patients deemed unable to understand and provide consent (e.g., severe cognitive impairment)
18 Years
99 Years
FEMALE
No
Sponsors
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AUSL di Modena - Ospedale Ramazzini di Carpi
UNKNOWN
AUSL di Modena - Ospedale di Mirandola
UNKNOWN
AUSL di Modena - Ospedale Civile di Sassuolo
UNKNOWN
AUSL di Modena - Ospedale di Pavullo nel Frignano
UNKNOWN
AUSL di Modena - Ospedale di Vignola
UNKNOWN
Azienda Ospedaliero-Universitaria di Modena
OTHER
Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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Principal Investigators
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Vincenzo Dario Mandato, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda USL - IRCCS di Reggio Emilia
Locations
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Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi
Carpi, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola
Mirandola, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale Pavullo nel Frignano
Pavullo nel Frignano, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo
Sassuolo, Modena, Italy
Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola
Vignola, Modena, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy
Azienda Ospedaliero - Universitario di Modena
Modena, , Italy
Countries
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References
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Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.
Colombo N, Sessa C, Bois AD, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Int J Gynecol Cancer. 2019 May 7;29(4):728-760. doi: 10.1136/ijgc-2019-000308.
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Fotopoulou C, Concin N, Planchamp F, Morice P, Vergote I, du Bois A, Querleu D. Quality indicators for advanced ovarian cancer surgery from the European Society of Gynaecological Oncology (ESGO): 2020 update. Int J Gynecol Cancer. 2020 Apr;30(4):436-440. doi: 10.1136/ijgc-2020-001248. Epub 2020 Feb 20. No abstract available.
Goenka L, Anandaradje A, Nakka T, Kayal S, Dubashi B, Chaturvedula L, Veena P, Durairaj J, Penumadu P, Ganesan P. The "collateral damage" of the war on COVID-19: impact of the pandemic on the care of epithelial ovarian cancer. Med Oncol. 2021 Sep 28;38(11):137. doi: 10.1007/s12032-021-01588-6.
Hudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15.
Mandato VD, Abrate M, De Iaco P, Pirillo D, Ciarlini G, Leoni M, Comerci G, Ventura A, Lenzi B, Amadori A, Rosati F, Martinello R, De Palma R, Ventura C, Belotti LM, Formisano D, La Sala GB; Gynecological Oncology Network of Emilia Romagna Region. Clinical governance network for clinical audit to improve quality in epithelial ovarian cancer management. J Ovarian Res. 2013 Mar 31;6(1):19. doi: 10.1186/1757-2215-6-19.
Mandato VD, Torricelli F, Uccella S, Pirillo D, Ciarlini G, Ruffo G, Annunziata G, Manzotti G, Pignata S, Aguzzoli L. An Italian National Survey on Ovarian Cancer Treatment at first diagnosis. There's None so Deaf as those who will not Hear. J Cancer. 2021 May 27;12(15):4443-4454. doi: 10.7150/jca.57894. eCollection 2021.
Mandato VD, Aguzzoli L. Management of ovarian cancer during the COVID-19 pandemic. Int J Gynaecol Obstet. 2020 Jun;149(3):382-383. doi: 10.1002/ijgo.13167. Epub 2020 Apr 29.
Mandato VD, Torricelli F, Mastrofilippo V, Pellegri C, Cerullo L, Annunziata G, Ciarlini G, Pirillo D, Generali M, D'Ippolito G, Leone C, Bologna A, Gasparini E, Palicelli A, Gelli MC, Silvotti M, Aguzzoli L. Impact of 2 years of COVID-19 pandemic on ovarian cancer treatment in IRCCS-AUSL of Reggio Emilia. Int J Gynaecol Obstet. 2023 Nov;163(2):679-688. doi: 10.1002/ijgo.14937. Epub 2023 Jun 26.
Other Identifiers
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247/2025/OSS/AUSLRE
Identifier Type: -
Identifier Source: org_study_id
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